Quality Assurance Manager
2 weeks ago
We are seeking a highly skilled Quality Assurance Manager to join our team at Daiichi Sankyo, Inc. This role will be responsible for ensuring the adherence to regulatory requirements and quality standards in our Quality Management System (QMS).
Key Responsibilities- Manage and maintain the QMS in accordance with regulatory requirements and industry standards.
- Ensure the implementation of global and harmonized quality standards and regulatory requirements for GMP areas.
- Develop and manage internal procedures to ensure adherence to quality standards and regulatory requirements.
- Collaborate with cross-functional teams to ensure alignment with industry regulations and best practices.
- Provide guidance and oversight of specific processes to ensure process excellence and compliance.
- Bachelor's Degree in a scientific discipline.
- 4+ years of experience in pharmaceutical, biologicals, or vaccines, including first-hand knowledge of drug manufacturing, packaging, QA, compliance, and audit.
- Proven experience working with various pharmaceutical dosage forms.
- Demonstrated expertise in working directly with multinational drug regulators and external partners.
- Solid understanding of quality management and continuous process improvement principles, including global cGMP requirements.
- Previous management experience is strongly preferred.
Must have ability to travel up to 10% including overnight travel (international and domestic).
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
-
Quality Assurance Manager
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Quality Assurance ManagerWe are seeking a highly skilled Quality Assurance Manager to join our team at Daiichi Sankyo, Inc. This role will be responsible for ensuring the quality of our products and processes, and for implementing and maintaining our Quality Management System (QMS).Key Responsibilities:Develop and implement quality policies,...
-
Quality Assurance Manager
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob Title: Quality Assurance ManagerJoin Daiichi Sankyo Group, a legacy of innovation, and contribute to the creation and supply of innovative pharmaceutical therapies.We are seeking a highly skilled Quality Assurance Manager to support and manage our Quality Management System (QMS) in accordance with regulatory requirements.Key Responsibilities:Ensure...
-
Quality Assurance Manager
1 month ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob DetailsJoin a Legacy of InnovationDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeQuality Assurance Manager, Pharmaceutical SystemsOverviewDaiichi Sankyo, Inc. is seeking a highly skilled Quality Assurance Manager, Pharmaceutical Systems to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesDevelop and implement...
-
AI/ML Quality Assurance Specialist
1 month ago
Basking Ridge, New Jersey, United States Net2Source Inc. Full timeJob Title: AI/ML QA EngineerCompany: Net2Source Inc.Location: Basking Ridge, NJDuration: 12+ MonthsPay Rate: $50.00 – 60.00/hr on W2Job Description:The AI/ML QA Engineer will be part of the Metrics, Analytics, Reporting and Solutions (MARS) team, responsible for delivering high-performance AI/ML models. This role involves quality assurance for AI and...
-
AI/ML Quality Assurance Engineer
1 week ago
Basking Ridge, New Jersey, United States Insight Global Full timeJob SummaryWe are seeking a highly skilled AI/ML Quality Assurance Engineer to join our team at Insight Global. As a key member of our MARS team, you will be responsible for delivering high-performance AI/ML models and ensuring their quality and reliability.Key ResponsibilitiesDevelop and execute testing strategies for AI/ML products, including test plans,...
-
AI/ML Quality Assurance Specialist
4 weeks ago
Basking Ridge, New Jersey, United States Net2Source Inc. Full timeJob Title: AI/ML QA EngineerNet2Source Inc. is a leading provider of total workforce solutions, recognized for its accelerated growth and global presence. We are seeking an experienced AI/ML QA Engineer to join our team.Job Summary:The AI/ML QA Engineer will be responsible for ensuring the quality and reliability of AI and machine learning models. This...
-
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Development Quality Management to lead our global pharmacovigilance (PV) system. As a key member of our team, you will be responsible for building strategic partnerships and directing risk-based quality management activities with key partners.Key ResponsibilitiesLead GVP-compliant activities...
-
Global Pharmacovigilance Quality Manager
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJoin a Legacy of InnovationDaiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. Leveraging our world-class science and technology, we strive to make a meaningful difference in people's lives.With over 120 years of scientific expertise and a...
-
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Development Quality Management to join our team at Regeneron Pharmaceuticals. This key position will guide and lead all aspects of quality and compliance within our global pharmacovigilance (PV) system.Key ResponsibilitiesLead GVP-compliant activities from a quality perspective in conjunction...
-
Validation Lead
1 week ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob Title: Validation Lead - ManagerJob Summary:Manage global computer system validation projects within BioSpace, Inc. for computerized systems supporting GxP and Non-GxP activities, ensuring compliance with global regulatory and company requirements.Key Responsibilities:Execute the global computer system validation methodology to determine the amount of...
-
Technical Program Manager
4 weeks ago
Basking Ridge, New Jersey, United States Verizon Full timeJob Title: Technical Program ManagerWe are seeking a highly skilled Technical Program Manager to join our team at Verizon. As a Technical Program Manager, you will be responsible for providing dedicated oversight and executive program support for Verizon's NYC OTI "TEA" backdrop contract.Key Responsibilities:Monitor supplier Key Performance Indicators (KPIs)...
-
Caregiver Coordinator
1 month ago
Basking Ridge, New Jersey, United States FirstLight Home Care of Morristown and Wayne Full timeJob Title: Client Care CoordinatorWe are seeking a compassionate and dedicated Client Care Coordinator to join our team at FirstLight Home Care of Morristown and Wayne. As a Client Care Coordinator, you will play a vital role in ensuring the highest level of care and support for our clients.Job Summary:This is a unique opportunity to make a difference in the...
-
Senior Validation Lead
1 week ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryAs a Senior Validation Lead at Daiichi Sankyo, Inc., you will be responsible for managing global DX computer system validation (CSV) projects. Your primary goal will be to ensure that computerized systems supporting GxP and Non-GxP activities are compliant with global regulatory and Daiichi Sankyo requirements.You will execute the Global DX...
-
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally. As a key member of the R&D team, you will be responsible for delivering the development and implementation of Research & Development (R&D) informatics...
-
Data Infrastructure Specialist
5 days ago
Basking Ridge, New Jersey, United States Ascendion Inc. (Formerly Collabera Inc.) Full timeAt Ascendion Inc. (Formerly Collabera Inc.), we are seeking a highly skilled Data Infrastructure Specialist to assist in designing and building the infrastructure required for storing, processing, and analyzing data.The ideal candidate will have experience in Big Data Technologies (Hadoop & Spark); AWS Technologies (EC2, EMR, S3, IAM); Quality Assurance...
-
Data Governance Specialist
2 weeks ago
Basking Ridge, New Jersey, United States Saxon Global Full timeJob SummaryThe Data Governance Specialist will support all organization-wide data governance activities and be responsible for deploying key Data Governance processes that pertain to the sourcing, management, development, and consumption of data assets across the enterprise. The position will focus on establishing and ensuring adherence to an enterprise data...
-
Senior Data Infrastructure Engineer
1 week ago
Basking Ridge, New Jersey, United States Ascendion Inc. (Formerly Collabera Inc.) Full timeAscendion Inc. (Formerly Collabera Inc.) seeks a skilled Senior Data Infrastructure Engineer to design and build the infrastructure required for storing, processing, and analyzing data.Key responsibilities include:Developing and implementing ETL (Extract, Transform, Load) pipelinesCreating and managing databases and data warehousesWorking with big data...
-
Data Governance Engineer
2 weeks ago
Basking Ridge, New Jersey, United States Saxon Global Full timeJob SummaryThe Data Governance Engineer will play a crucial role in supporting organization-wide data governance activities, ensuring the deployment of key Data Governance processes that pertain to the sourcing, management, development, and consumption of data assets across the enterprise. This position will focus on establishing and ensuring adherence to an...
-
Director, Informatics Solutions
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryDeliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs,...